We are currently seeking a Device Senior Scientist for our Global Pharmaceutical client based in the Dublin area, due to major growth at the company they are looking to add to their team.
Ref: 5040182
Role/Opportunity:
• Device development engineer/scientist is responsible for leading device development and troubleshooting activities within the R&D Pilot Plant facility.
• Works with other R&D colleagues on inhaler development projects to execute product development activities and technical transfer of new products into the pilot plant in Dublin and subsequently into the co-located Commercial Facility.
• Works closely with the UK R&D team to integrate device development activities across both sites. Local subject matter expert in device development processes, technologies and overall device understanding to support clinical manufacturing needs, registration activities and interface with commercial manufacturing colleagues.
• Produces high quality results within a cGMP environment for the team.
• Works with external parties to support the development of the device and packaging needs for the inhaler program, and in the transfer of technical and operational process and product development understanding in to the Commercial Facility.
Skills/Experience:
• Minimum of a third level qualification in Chemistry or related discipline
• At least 5 years relevant technical experience in a highly regulated environment (IMB/FDA)
• An understanding of Lean Principles/Operational Excellence tools and “hands on” implementation of same in a pharmaceutical environment.
• Strong organisational skills with the ability to multitask and prioritise workload in a fast moving environment
• Excellent verbal, written and interpersonal communication skills with the ability to interact effectively at all levels within the organisation
• Thorough understanding of device development, industrialization, design control and operations activities in an R&D and/or a GMP manufacturing environment. Understanding of the impact of device assembly processes on product performance.
• Experience of device assembly and development activities and operations for device systems (inhalation product development preferred) in a GMP environment.
• Leadership of projects or teams in a device or pharmaceutical environment.
• Practical experience of device development activities.
• Experience of Technical Transfer of products and processes into a Commercial Manufacturing
Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout Ireland, Asia, UK and Australia
For more information go to http://www.berkley-group.com
To apply: If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Sinéad Hawes on +353 (0)1 8724667 or send your CV to science@berkley-group.com
